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EP2967711B1 - Elektrochirurgische instrumente mit mehreren behandlungsmodi - Google Patents

Elektrochirurgische instrumente mit mehreren behandlungsmodi Download PDF

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Publication number
EP2967711B1
EP2967711B1 EP14762910.9A EP14762910A EP2967711B1 EP 2967711 B1 EP2967711 B1 EP 2967711B1 EP 14762910 A EP14762910 A EP 14762910A EP 2967711 B1 EP2967711 B1 EP 2967711B1
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EP
European Patent Office
Prior art keywords
return
electrode
electrodes
electrosurgical
instrument
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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EP14762910.9A
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English (en)
French (fr)
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EP2967711A2 (de
EP2967711A4 (de
Inventor
Albert M. JUERGENS
Frank D'amelio
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Cynosure LLC
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Cynosure LLC
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Publication of EP2967711A4 publication Critical patent/EP2967711A4/de
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B18/1233—Generators therefor with circuits for assuring patient safety
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1477—Needle-like probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/16—Indifferent or passive electrodes for grounding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452—Skin
    • A61B2018/00458—Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains
    • A61B2018/00464—Subcutaneous fat, e.g. liposuction, lipolysis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00666—Sensing and controlling the application of energy using a threshold value
    • A61B2018/00678—Sensing and controlling the application of energy using a threshold value upper
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A61B2018/00708—Power or energy switching the power on or off
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    • A61B2018/00773—Sensed parameters
    • A61B2018/00791—Temperature
    • A—HUMAN NECESSITIES
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    • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B2018/00994—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combining two or more different kinds of non-mechanical energy or combining one or more non-mechanical energies with ultrasound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B2018/124—Generators therefor switching the output to different electrodes, e.g. sequentially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/1253—Generators therefor characterised by the output polarity monopolar
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/126—Generators therefor characterised by the output polarity bipolar
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1407—Loop
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1467—Probes or electrodes therefor using more than two electrodes on a single probe
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1497—Electrodes covering only part of the probe circumference
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/16—Indifferent or passive electrodes for grounding
    • A61B2018/162—Indifferent or passive electrodes for grounding located on the probe body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/16—Indifferent or passive electrodes for grounding
    • A61B2018/165—Multiple indifferent electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B2018/2035—Beam shaping or redirecting; Optical components therefor
    • A61B2018/20361—Beam shaping or redirecting; Optical components therefor with redirecting based on sensed condition, e.g. tissue analysis or tissue movement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/328—Applying electric currents by contact electrodes alternating or intermittent currents for improving the appearance of the skin, e.g. facial toning or wrinkle treatment

Definitions

  • the inventive subject matter is directed to a multimode surgical instrument that provides for (1) multiple modes of electrosurgical operation, and/or (2) multiple modes of surgical treatment.
  • the inventive subject matter is directed to a multimode electrosurgical system with a set of return electrodes that can be variably engaged into operation to control a temperature at select electrodes in the set or at a target area adjacent the electrodes.
  • the inventive subject matter while adaptable to many surgical and therapeutic applications, is particularly suited for use in a system for liposuction. Accordingly, hereafter, a liposuction application will generally be used to illustrate the principles of the inventive subject matter and various possible embodiments thereunder.
  • a liposuction procedure involves the insertion of a cannula into an area of a patient's body where subcutaneous fat tissue 1 is present.
  • the cannula includes a valve assembly that couples to a suction source.
  • the operator applies suction to the cannula or other hollow shaft to remove fatty tissue that is disrupted by a disrupter associated with the cannula.
  • the disrupter may be a mechanical element, such as blade, or an energy emitter for disruption by targeted energy.
  • the tip of a cannula can be configured to scrape fat tissue.
  • the cannula supports a laser device or ultrasonic device for targeting disruptive energy into tissue to fragment, melt, or vaporize tissue.
  • One disadvantage of typical laser-liposuction devices is that the laser fiber is in placed in the main channel or lumen of the cannula so there cannot be simultaneous melting of fat by the laser and suction of the disrupted fatty materials.
  • Liposuction procedures may be dry field, wet field, or semi-wet field procedures.
  • a dry field the cannula is inserted into the target area without the introduction of any fluid.
  • a wet field a fluid is introduced into the target area through a lumen in the instrument.
  • the introduced fluid may serve various functions. For example, it can be an irrigant that facilitates the suctioning of disrupted tissue.
  • a semi-dry field is one where the target area is lightly irrigated. Accordingly, in a liposuction procedure the suctioned material may be primarily fatty material or a mixture of fatty material and an introduced fluid.
  • a significant disadvantage of all liposuction procedures is that when subcutaneous fat is removed from below the dermis, skin tension is reduced causing unsightly wrinkling, sagging or other surface irregularities in the skin. The degree of such irregularities may necessitate a surgeon to excise skin tissue and suture the exposed edges to tighten the skin surface. This is highly undesirably on several fronts, including the creation of scars and additional surgical risk.
  • US-A-2003 163 178 discloses a electrosurgical system that can be switched between a monopolar mode and a bipolar mode.
  • US-A-2009 138011 discloses an apparatus for preventing return electrodes in a radio frequency ablation system from overheating.
  • the inventive subject matter is directed to a hybrid electrosurgical system and related instruments with a first electrode configuration that operates in a bipolar mode and second electrode configuration that operates in a monopolar mode.
  • the inventive subject matter is directed to a multimode electrosurgical system with a set of return electrodes that can be variably engaged into operation to control a temperature at select electrodes in the set or at adjacent or nearby tissue.
  • the instrument includes an active electrode, i.e., an electrode that is energizable and configured to deliver radio frequency ("RF") energy to a target area in or on a patient's body.
  • the active electrode may be configured for vaporization, cutting, coagulating, ablating, or fulgurating of target tissue using parameters that are well known in the art. Electrode configurations for specific effects are known to persons skilled in the art. For example, electrodes with low surface area points of contact will be more suited for cutting of tissue, while broader surface areas are more suited for coagulating of tissue. The desired effect is also dependent on the frequency, power, waveform, and duty cycles of RF energy input though the electrode.
  • ECU Electrosurgical Control Unit
  • electrosurgical instruments include at least one return electrode, and a current path is defined between the active and return electrode.
  • one or more return electrodes are disposed on the body of the instrument. The return electrode or electrodes provide a return path to the generator.
  • the return electrode is not on the instrument but is remotely placed against a portion of the patient's body, typically against the buttocks.
  • Such return electrodes may be referred to in the art as "patient pads.” They have sufficiently broad surface area so that current density is safely reduced to avoid burning the patient.
  • One advantage of the inventive subject matter is that it provides multiple electrode configurations that allow for varying modalities of polarity: strictly bipolar operation, strictly monopolar operation, or alternating between bipolar and monopolar operation. As discussed in more detail below, the instrument shown in the Figures is configured for such varying modes of electrosurgical treatment.
  • the inventive subject matter generally relates to surgical and therapeutic systems and related instruments that provide multiple modes of treatments, at least one being an electrosurgical treatment.
  • the Figures show an instrument with the following modes: a first mode is used to perform liposuction on a patient; and a second mode is used to perform skin tightening in the same area as the liposuction. The second mode may be performed concurrently or separately from the liposuction mode.
  • Fig. 1 shows a system 9 that includes an instrument 10 and an associated electrosurgical control unit ("ECU") 11 that supports electrosurgical modes of operation for the instrument.
  • the electrosurgical instrument 10 includes a working portion 12 that extends distally from a handle or handpiece 14, which may have controls for the user to activate or deactivate functions for the instrument.
  • Fig. 2 shows a cross-section of the distal tip portion of the instrument taken along line 2-2 in Fig. 1 .
  • the working portion is typically elongate and is intended for use in or over a target area of a patient's body.
  • the handle may also serve as a housing for components, e.g., for circuitry. In other instances, a graspable handle 14 is spaced from the housing of circuits.
  • the distal end portion 16 of the working portion includes one or more electrodes, such as electrodes 18, 20a, 20b and/or 28.
  • the system includes circuits or communication channels, e.g., C 1 - C 4 , for activity and controlling electrodes and other components on the instrument.
  • the ECU is configured to provide power to the instrument for energizing one or more active electrodes that may be disposed on the instrument. As described more fully below, the ECU can be configured to provide energy having a selected radio frequency and waveform.
  • a cable extends between an electrical connector on the ECU control and an electrical connector on the electrosurgical instrument to electrically couple one or more conductive elements on or within the instrument to one or more corresponding conductive elements of the controller.
  • the inventive subject matter overcomes the disadvantages in the field of liposuction by providing for simultaneous disruption of fatty tissues and skin tightening in the target area of a patient.
  • Heat induces collagen denaturation and collagen contraction, which in turn leads to new collagen formation in the dermis, which also results in epidermal tightening.
  • skin tightening is believed to be accomplished in the following manner.
  • One or more return electrodes e.g., 20a, 20b
  • return electrodes e.g., 20a, 20b
  • the return electrodes are conductive elements that conclude a current path (e.g., 22a, 22b) with the active electrode (e.g., 18). Heat is generated along the path, as resistive heating from the current. ( Figs. 3a-3b .) Accordingly, non-ablative, thermal energy emanates from a current path. The heat transfers to the tissue adjacent the current path and/or the return electrodes.
  • the active electrode 18 is configured as a ring disposed about the distal opening 24 of working portion 12, which in this case is a cannula with one of more lumens 25.
  • the inventive subject matter is not limited to ringshaped active electrodes. Any other shape that achieves a desired effect can be used.
  • the active electrode at the distal end of the instrument 10 could have a bull-nose like configuration.
  • a pair of return electrodes is disposed in line with the longitudinal axis of the cannula, and on the outer surface of the cannula.
  • the instrument or associated ECU is configured with circuitry to allow for manual or automatic switching on and off of the return electrodes according to predefined parameters such as temperature or duty cycles.
  • the ECU also includes similar manual or automatic switching circuitry for switching on and off a patient pad coupled to the system.
  • the cannula has side walls defining at least one lumen (e.g., 25) for transporting materials or things from or to the target area of a patient.
  • the cannula shown in the Figures has a circular cross-section, but the cross-section can vary. For example, it can be an oval, square, hexagonal, a complex curve, or any other shape that defines a lumen or serves an intended purpose.
  • the working portion may also have multiple lumens of desired cross-sections that run in parallel fashion along the working portion.
  • a first lumen could be connected to a suction source for applying suction at a target site and removing loose materials. That same lumen could optionally be used for other purposes.
  • a second lumen could be used to introduce another instrument or tool, such as a laser fiber, that delivers energy to the target site or to introduce a fluid or other material to the target site.
  • a second or third lumen could be used to provide a channel for introducing an endoscope for viewing a target area.
  • the distal end portion 16 of the instrument could also include a built-in image sensor for imaging at a target site, and optionally a light source, both of which are well-known features in the field of endoscopy and minimally invasive surgery.
  • the inventive subject matter is not limited to that configuration.
  • the distal portion 16 of the shaft could be angled off of a proximal, straight portion, i.e., a jog off the major longitudinal axis of the instrument. Such angling could allow the return electrodes to make better contact with tissue when the targeted tissue 1 is parallel to the shaft.
  • the return electrodes could be placed on the angled portion when the targeted tissue is transverse to the major, longitudinal axis of the working portion.
  • a cannula of about 4mm outer diameter is suitable.
  • the return electrode configuration on such a cannula may be about 7mm wide and about 23mm long (or other dimensions of similar surface area), as a single return electrode unit or aggregation of smaller return electrode units (e.g., return electrodes 20a and 20b).
  • the return electrodes may be made of a suitable conductive material such as aluminum, copper, silver, or alloys of conductive materials.
  • the return electrodes may be disposed on the cannula as a thin foil or sheet of conductive material. They could also be formed as a coating on the surface of the cannula by other means.
  • a vapor deposition or metal printing technique could be used to metallize an area of a cannula.
  • cannulas and other working portion configurations are typically made of a conductive material, e.g., stainless steel, a non-conductive layer 26 of material will be disposed between the main body (or other conductive substrate) of the cannula and the return electrodes.
  • the return electrodes may have varying shape and surface area, but for use in skin tightening they would at least be configured for a non-ablative, thermal effect on tissue.
  • a current path is defined by (1) one or more active electrodes (e.g., 18), which are used to disrupt fatty tissue, disposed at the distal end portion 16 of the cannula 12; and (2) one or more operational return electrode or electrodes (e.g., 20a and 20b) that are spaced from the active electrode(s) and disposed on the outer surface of the cannula.
  • the current flow occurs along the defined path(s) 22a and/or 22b when the instrument is operated in bipolar mode.
  • a remote electrosurgical generator supplies the power to drive the current. As the instrument is steadily used in a procedure, the area of the current path leading to the operational return electrodes will heat.
  • each active electrode may be placed in a switchable circuit with a monopolar operating mode of the generator and one or more patient pads 28 on the exterior surface of the patient's body.
  • the dermis is maintained between a target temperature range of from 39 degrees or thereabout C to 55 degrees C or thereabout, with a temperature of 42 degree or thereabout being suitable.
  • Tissue temperature may be monitored directly or by approximation by monitoring temperatures at the return electrode adjacent the treated tissue.
  • the system may be configured with upper and lower limits for switching the return electrodes from bipolar mode to monopolar mode.
  • the functioning return electrodes are the onboard return electrodes (e.g., 20a and/or 20b) on the surface of the cannula.
  • the onboard return electrodes are deactivated from being in circuit with the generator and at least one patient pad 28 in contact with a patient is activated into a circuit in communication with the generator.
  • the broader surface area of the patient pad provides substantially reduced current density and consequently relatively little heating.
  • the target tissue 1 adjacent the return electrodes 20a, 20b on the cannula can cool back into the defined temperature range for skin tightening.
  • the patient pad may be maintained on the outside of the epidermis at the area of dermis being treated, or thereabout, thereby providing a more direct and efficient current path.
  • a monopolar patient pad is an electrode of about 10.16 cm by 12.7 cm (4 inches by 5 inches) (or different dimensions or shapes but similar surface area). If multiple pads are used, they can be selectively activated and deactivated. For example, if a first pad is heating beyond predefined limits, a second pad could be activated, with or without deactivating the first pad.
  • the inventive subject matter contemplates a system with one or more return pads 28.
  • the ratio of the area of the return pad relative to the area of the active portion (active end-effector) determines the relative proportion of energy that is deposited at each location. The larger the ratio, the greater the percentage of heat generated in the tissue at the smaller terminus.
  • the system switches between the various return pads.
  • the return pad is coupled to the hand of the physician operating instrument 10.
  • the physician it is not unusual for the physician to apply external pressure to the patient over the area being evacuated.
  • the return pad is thus always maintained in an ideal location relative to the treatment area.
  • the inventive subject matter contemplates systems and methods related to the coupling of a return pad on the user's hand.
  • a return pad could, for example, be in glove form or have finger straps or bands to enable the pad to secure to the user's hand or fingers.
  • the inventive subject matter contemplates components and methods for control over impedance during a procedure.
  • contact between the patient and the return electrode can be intermittent. Intermittent contact results in a loss of energy flow to the active electrode and may also generate unwanted sparking at the return electrode.
  • a solution to this is to have at least one return electrode designated for constant service during a procedure and one or more other return electrodes, such as those on the cannula or coupled to a user's hand, that can have varying degrees of contact, from no contact to full contact with treatment areas.
  • the return electrode designated for constant service can control the flow of energy between the various pads so as to (1) maintain both a constant flow of energy and (2) help reduce or eliminate unwanted sparking or deactivation of the active electrode.
  • temperature sensors may be optionally incorporated into the instrument 10, as seen in Figs 1-2 , for example.
  • one or more thermistors may be incorporated into the instrument.
  • separately readable thermistors 30a, 30b are disposed adjacent to each return electrode 20a, 20b to measure the temperature in the proximity of the electrodes that results from heat transfer.
  • the thermistors are integrated between the lower surface of the return electrodes 20a, 20b and the top surface of the layer 26 of insulating material on which the return electrodes are disposed.
  • An infrared sensor may also be disposed on or off instrument 10 and associated with the return electrodes or otherwise to monitor temperature at the target site.
  • Figs 3A and 3B illustrate a distal working portion 16 of a cannula 12 with two return electrodes 20a, 20b.
  • the distal portion 16 is at a subcutaneous layer of fatty tissue 1, which is the target for liposuction.
  • a first mode of operation ( Fig. 3A )
  • a first return electrode 20a is in operation and working within a temperature range for skin tightening.
  • the globular area represents fatty tissue in front of the distal tip portion 16 of the instrument.
  • An active electrode 18 at the tip is energized and disrupting that tissue.
  • Above and parallel to the distal working portion is the underside of the dermis 2.
  • the current path 22a is indicated by the arcing lines run from the distal tip to a first, distal return electrode 20a. This represents a current path from the active electrode 18 to the first return electrode 20a.
  • the second return electrode 20b is activated into operation.
  • This is indicated by a second set of arcing lines for a current path 22b, which extends beyond the first current path 22a all the way to the second return electrode 20b.
  • Modulation of tissue temperature can be achieved by alternating between different return electrodes in a set of return electrodes included in a system, e.g., the electrodes disposed on a working portion of an instrument and/or a patient pad.
  • Each return electrode may be separately addressable and switchable. This allows for parallel or sequential use of the return electrodes. It also allows for variable overall current densities based on the aggregate surface area of the return electrodes in service. For example, if a first return electrode is too hot, a second one can be activated into service to increase the aggregate surface area and thereby decrease overall heating.
  • some return electrodes may always be kept in service to heat tissue for skin tightening while others are in a cooling phase.
  • the inventive subject matter is directed to systems and methods for controlling the temperature of tissue in contact with a defined set of return electrodes by varying the aggregate surface area of all return electrodes (whether in a bipolar or monopolar circuit) that are in a current path with an active electrode.
  • the instrument 10 optionally may include one or more apertures (e.g., 32a, 32b, 32c) about the return electrodes 20a, 20b that are in communication with channels (e.g., 17) in the instrument that can couple with a suction source (not shown).
  • a suction source not shown
  • the application of suction will cause the instrument to draw up against adjacent tissue to bring the return electrode in contact or closer contact with the tissue that is targeted for heating and tightening.
  • the apertures 32a, 32b, 32c are in line with the return electrodes 20a, 20b.
  • the apertures could be spaced along one or both sides of the electrodes in a generally parallel fashion.
  • the instrument is configured for establishing orientation with target tissue so that return electrodes may be positioned adjacent to target tissue.
  • the side 34 of the shaft or handle 14 in line with the return electrodes 20a, 20b could have a different shape or dimension than other sides.
  • cannula 12 is connected to a handle 14 having a generally triangular cross section ( Figs. 1 and 5 ).
  • One side 34 of the handle which corresponds to the side on the cannula where the return electrodes are disposed, has a relatively broad, planar surface.
  • the other two surfaces 35 are not planar but arcuate.
  • other ways of determining orientation are contemplated.
  • orientation could be determined using an imaging sensor that allows for viewing from the return electrode side of the instrument or inertial sensors that follow motion.
  • Another approach is color coding or placing of any other graphical indicator (e.g., letters, words, numbers, symbols) or other visible indicator (e.g., light emitters) on a side of the handle or working portion that marks that side as corresponding to a predefined area on the instrument.
  • This approach is not limited to use with return electrodes but also can be used to indicate the orientation of other functional features in the instrument. If there are multiple placements of return electrodes or other features spaced about the circumference, the handle or other portion of the instrument that extends from a target can be coded with corresponding indicia of orientation.
  • the inventive subject matter is directed to systems and methods for modulating the form of energy delivered through one or more active electrodes associated with an instrument and/or modulating the aggregate surface area of operational return electrodes (bipolar and monopolar). These can be achieved through a set of computer executable instructions stored in volatile or non-volatile memory associated with the instrument. The instructions can be executed by a computer processor associated with an ECU 11 that is coupled to the instrument. Looking at Figs. 6 and 7 , first and second theoretical graphs of Power (Y-axis)/Impedance (X-axis) are shown. Higher powers means the active electrode will be more effective at delivering energy to tissue for an intended surgical effect, such as cutting or coagulating. In Fig.
  • curve I shows how power varies with impedance in a relative broad bell-shaped curve. This curve indicates how power would vary for some common ESUs.
  • Curve II represents a power profile for a more specialized ESU. This represents a profile where peak power is in a narrow band. Power quickly falls off as impedance increases or decreases. This profile could be used where the peak power corresponds to tissue type having an inherent impedance under the peak. This profile therefore allows for a self-limiting effect on tissue. For example, it could be used to coagulate bloody, ulcerous tissue. As the tissue is coagulated, its impedance quickly increases and power drops, which prevents damage to tissue surrounding the target tissue.
  • a first curve I represents a sometimes desirable flat power curve for working with a broad range of tissues where defined power output can be maintained across a range of impedances corresponding to the varying impedances of different kinds of tissues.
  • a second curve II represents a selected peaking of power at a defined impedance.
  • the peak power is at relatively high impedance generally corresponding to the impedance of fatty tissue, such as is encountered during liposuction. This allows the system to selectively disrupt fatty tissue relative to other kinds of tissue. In other words, there is a high coupling efficiency between the power profile and the target tissue. Accordingly, the selectivity allows for less power delivery to lower impedance, non-target tissues, such as veins, arteries and muscle. Such tissues are therefore better protected from accidental trauma.
  • ECU systems may be used to create desired power profiles.
  • some known ECUs provide three output terminals, with one of the terminals being an energizable terminal for conveying energy, e.g., RF energy, to an energizable element of a handpiece.
  • Such an ECU is usually configured to energize the energizable terminal when a circuit between the two remaining output terminals is completed, as through the closing of a user-actuated switch or an automatically programmed switch.
  • a programmed switch operates depending on predefined temperature limits for the points on the instrument and/or patient target area.
  • ECUs include those manufactured by Ellman International, such as those under the brand SURIGTRON and described in U.S. Patent No. 6,652,514 .
  • the SURGITRON provides a three-wire output connector for powering and controlling electrosurgical handpieces.
  • Conventional ECUs can generate, for example, one or more radio-frequency (RF) modulated waveforms, e.g., at a frequency of about 4 megahertz (MHz), which can be delivered to a target site by way of an electrosurgical handpiece having an energizable electrode defining an active surface.
  • RF radio-frequency
  • ECUs configured for both monopolar and bipolar operations have been developed by the assignee of this application and are disclosed in US 7,479,140 , the contents of which are incorporated herein by reference in their entirety,
  • an electrosurgical system can be configured for ablative and/or non-ablative electrosurgery.
  • an ablative procedure is one where the electrode and power settings result in cutting, coagulation, vaporization or other such traumatic disruption to the integrity of treated tissue
  • a non-ablative procedure is one where such cutting, coagulation, vaporization or other such traumatic disruption to the integrity of treated tissue does not result.
  • An electrosurgical instrument can be configured provide a given combination of operating parameters suitable for achieving a desired therapeutic outcome based on a user's selection of therapeutic outcome and, for example, configuration of energizable electrode. Some electrosurgical instruments are configured to recognize a configuration or type of energizable electrode automatically.
  • a typical instrument configured for use in the surgical market segment delivers a peak output power of about 300 watts RMS (e.g., between about 290 Watts RMS and about 310 Watts RMS) in a cutting mode, and a lower peak power corresponding to each of a coagulate and fulgurate modes.
  • a typical instrument configured for use in the aesthetic market segment delivers a peak output power of about 400 watts RMS (e.g., between about 385 Watts RMS and about 415 Watts RMS) in an "aesthetic mode" (e.g., skin tightening), about 300 Watts RMS in a surgical cutting mode and a lower peak power corresponding to each of a coagulate and fulgurate mode.
  • an "electrosurgical treatment mode” means a distinct configuration of an electrosurgical instrument corresponding to a distinct perceived result arising from a given user input.
  • Each distinct configuration can correspond to a physical configuration, a software configuration, a firmware configuration, or a combination thereof.
  • an electrosurgical mode is defined by a waveform comprising a given frequency, duty cycle, and amplitude (e.g., a maximum power output).
  • amplitude e.g., a maximum power output
  • electrosurgical treatment mode means a distinct configuration of an electrosurgical instrument corresponding to a distinct perceived result arising from a given user input.
  • Each distinct configuration can correspond to a physical configuration, a software configuration, a firmware configuration, or a combination thereof.
  • U.S. Patent Application No. 11/897,035 teaches that operational modes include monopolar and/or bipolar activation, and a user selection of carrier frequency and modulating waveforms representing one of the four operating modes.
  • the modulation frequencies will vary from 0 Hz to 35 KHz.
  • the four operating electrosurgical modes are represented by cutting: CW output with maximum (or 90%-100%) average power obtained with full-wave rectified and filtered carrier waveforms; cutting/coagulation: approximately 25%-75% average power output achieved with amplitude modulated or pulsed sine wave" with a pulse” frequency on the order of 100 to 5000 cps; hemostasis: approximately 10%-40% average power output achieved with amplitude modulated or pulsed sine wave with a "pulse" frequency on the order of 100 to 5000 cps with a lower duty cycle than seen on the cutting/coagulation mode; fulgurate (or Spark-Gap Wave): approximately 20% average power output achieved with very short repeating bursts of high voltage energy, with on the order of 100 to 5000 cps. The percentages given are with respect to the maximum value.
  • the monopolar operation is preferred for smooth cutting and combined cutting and coagulation
  • bipolar operation concentrates the electrosurgical currents between the active and return electrodes, and is thus preferred for local hemostasis with lower power
  • many surgical situations may arise where it is preferred that higher power electrosurgical currents are applied with the bipolar operation and lower power electrosurgical currents with the monopolar operation.
  • the first carrier frequency is in the range of about 3.8-4.0 MHz or thereabout
  • the second carrier frequency is in the range of about 1.7-2.0 MHz or thereabout
  • the third carrier frequency is in the range of about 400-600 KHz or thereabout.
  • the values are 4 MHz or thereabout, 1.71 MHz or thereabout, and 500 KHz or thereabout.
  • the first, second and third carrier frequencies are derived by division by 2 upon selection from RF carrier generators at double the desired frequencies which simplifies the RF generator selection circuitry.
  • Instruments as disclosed herein can be programmed with one or the other waveforms to correspond to an end-user's preferred use (e.g., one end-user might be more likely to cut the first type of tissue, so an instrument provided to that end user can be programmed to provide the corresponding more effective waveform when a "cut" function is selected).
  • Such market-segment differentiation using the same base hardware can permit a manufacturer to enjoy economies of scale during production, while also being able to supply each distinct market segment with suitable, competitive product.

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Claims (12)

  1. Ein elektrochirurgisches Multimoden-System (9), das ein elektrochirurgisches Instrument (10) umfasst, wobei das Instrument (10) einen Arbeitsabschnitt (12) mit einer ersten Elektrodenkonfiguration, die in einem bipolaren Modus arbeitet, und einer zweiten Elektrodenkonfiguration, die in einem monopolaren Modus arbeitet, aufweist, wobei der Arbeitsabschnitt eine aktive Elektrode (18) und eine Vielzahl von Rücklaufelektroden (20a, 20b) umfasst, wobei jede Rücklaufelektrode (20a, 20b) separat adressierbar ist, wobei mindestens eine der separat adressierbaren Rücklaufelektroden (20a, 20b) kontinuierlich betreibbar ist, um einen aktivierten Strompfad (22a) mit der aktiven Elektrode (18) aufrechtzuerhalten, wobei mindestens eine andere separat adressierbare Rücklaufelektrode (20a), 20b) selektiv aktivierbar ist, um eine kontinuierliche Steuerung eines aggregierten Oberflächenbereichs der in Betrieb befindlichen Rücklaufelektroden und dadurch eine kontinuierliche Steuerung einer an eine Behandlungsstelle angelegten Stromdichte bereitzustellen, wobei das elektrochirurgische System (9) so konfiguriert ist, dass es eine Spitzenleistung bei einer definierten Impedanz liefert, die einem Impedanzwert von Fettgewebe entspricht, und wobei die Leistung mit zunehmender oder abnehmender Impedanz relativ zu der definierten Impedanz abnimmt, wodurch ein selbstbegrenzender Effekt auf Gewebe bereitgestellt wird.
  2. Elektrochirurgisches System nach Anspruch 1, wobei die Mehrzahl von Rücklaufelektroden (20a, 20b) einen Satz von zwei oder mehr Rücklaufelektroden (20a, 20b) umfasst, die selektiv in Betrieb genommen werden können, um eine Temperatur an einer oder mehreren Elektroden in dem Satz von zwei oder mehr Rücklaufelektroden (20a, 20b) zu steuern.
  3. Elektrochirurgisches System nach Anspruch 2, bei dem jede von mindestens zwei Rücklaufelektroden in dem Satz von zwei oder mehr Rücklaufelektroden (20a, 20b) separat in Betrieb genommen werden kann, relativ zu wenigstens einer anderen Rücklaufelektrode in dem Satz.
  4. Elektrochirurgisches System nach Anspruch 1, ferner umfassend einen Schaft, der ein Lumen (25) definiert, und eine Ventilanordnung, die an eine Saugquelle koppelbar ist, die mit dem Lumen (25) in Fluidverbindung tritt.
  5. Elektrochirurgisches System nach Anspruch 2, bei dem ein oder mehrere Temperatursensoren (30a, 30b) mit jeder Rücklaufelektrode (20a, 20b) verbunden sind.
  6. Elektrochirurgisches System nach Anspruch 5, bei dem jede separat adressierbare Rücklaufelektrode (20a, 20b) mit einem separat ablesbaren Temperatursensor (30a, 30b) verbunden ist.
  7. Elektrochirurgisches System nach Anspruch 6, ferner umfassend eine Schaltung zum automatischen Ein- oder Ausschalten mindestens einer Elektrode (20a, 20b) in Übereinstimmung mit einer Vielzahl von vordefinierten Parametern, wobei mindestens einer der Parameter ein Temperaturmesswert aus der Nähe mindestens einer Rücklaufelektrode (20a, 20b) ist.
  8. Elektrochirurgisches System nach Anspruch 1, wobei das System so konfiguriert ist, dass es eine oder mehrere Rücklaufelektroden (20a, 20b) in Abhängigkeit von den Messwerten eines oder mehrerer Temperatursensoren (30a, 30b), die mit der einen oder den mehreren Rücklaufelektroden (20a, 20b) oder einem Zielbereich verbunden sind, aktiviert oder deaktiviert.
  9. Elektrochirurgisches System nach Anspruch 1, wobei das System ferner einen Prozessor und ein Speichermedium mit gespeicherten ausführbaren Befehlen umfasst, die, wenn sie ausgeführt werden, den Prozessor (11) veranlassen, eine oder mehrere Frequenzen, eine Leistung, eine Wellenform und einen Arbeitszyklus der HF-Energieeingabe durch die aktive Elektrode in Übereinstimmung mit einem gewünschten elektrochirurgischen Operationsmodus zu steuern.
  10. Elektrochirurgisches System nach Anspruch 9, wobei das System so konfiguriert ist, dass es die Erwärmung an den Rücklaufelektroden (20a, 20b) durch Modulation der Arbeitszyklen für den Betrieb der Elektroden moduliert, wobei die Modulation auf den Messwerten von einem oder mehreren Temperatursensoren (30a, 30b) in dem System basiert.
  11. Elektrochirurgisches System nach Anspruch 1, wobei das System so konfiguriert ist, dass es eine oder mehrere zusätzliche Rücklaufelektroden (20a, 20b) aktiviert, die in Betrieb genommen werden, wenn eine Temperaturgrenze von einem oder mehreren Temperatursensoren (30a, 30b) erfasst wird.
  12. Elektrochirurgisches System nach Anspruch 2, ferner umfassend eine von dem Instrument (10) getrennte Rücklaufelektrode (28), die in der monopolaren Betriebsart gegen den Körper eines Patienten einsetzbar ist.
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US20200093533A1 (en) 2020-03-26
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US20140276659A1 (en) 2014-09-18
US10492849B2 (en) 2019-12-03
EP2967711A4 (de) 2016-12-07
WO2014145148A2 (en) 2014-09-18
US11389226B2 (en) 2022-07-19

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